Download GTU BE/B.Tech 2019 Winter 7th Sem New 2173602 Process Technology Of Drugs And Intermediates Question Paper

Download GTU (Gujarat Technological University) BE/BTech (Bachelor of Engineering / Bachelor of Technology) 2019 Winter 7th Sem New 2173602 Process Technology Of Drugs And Intermediates Previous Question Paper

1
Seat No.: ________ Enrolment No.___________

GUJARAT TECHNOLOGICAL UNIVERSITY

BE - SEMESTER ? VII (New) EXAMINATION ? WINTER 2019
Subject Code: 2173602 Date: 23/11/2019

Subject Name: Process Technology of Drugs & Intermediates
Time: 10:30 AM TO 01:00 PM Total Marks: 70

Instructions:
1. Attempt all questions.
2. Make suitable assumptions wherever necessary.
3. Figures to the right indicate full marks.

MARKS

Q.1 (a) Define Process safety. Briefly explain the types of hazards 03
(b) Describe Simulated Bed Chromatography with a schematic diagram. 04
(c) Describe the resolution of Racemates by (1). Direct crystallization method,
(2). Preferential crystallization method with example and schematic
diagrams.
07
Q.2 (a) Why Good manufacturing Practices (GMP) are to be followed in Pharma
Industries? Where these guide lines are applicable? What are the importance
of GMP
03
(b) Describe the steps which are to be taken for optimizing reactions 04
(c) Briefly discuss the techniques for identifying exothermicity & gas
generation. Illustrate the use of calorimetry with three examples.
07
OR
(c) Discuss about (1). Choosing a Phase transfer catalyst (PTC), (2). How
selectivity in PTC can be achieved. Illustrate the advantages of using PTC in
any two organic synthesis
07
Q.3 (a) Why enzymes are preferred as catalyst? Describe the regulation of enzymes 03
(b) Define Chiral auxiliary.With a schematic diagram, illustrate the use of
Chemical Auxillary. Give one example of the use of Chiral auxillary
04
(c) What are the factors to be considered while choosing a solvent. Briefly
describe them.
07
OR
Q.3 (a) Discuss about Marckwald principle & Reciprocal resolution with example 03
(b) Discuss ?Residual solvents?. Write a note on classification of solvents by
risk assessment.
04
(c) Describe, (1). Adulterated drug, (2). Deviation investigation, (3). CAPA 07
Q.4 (a) Write a note on Supercritical liquid as solvent 03
(b) Discuss the steps to be taken for optimizing the mesylation of Propargylic
alcohol
04
(c) Write a note on classifications of Enzymes. Discuss in detail the Lipases &
Esterases and their catalytic reactions.
07
OR
Q.4 (a) Write a note on Enzymes & their sources. 03
(b) Define ?Reagent?. List out the factors to be considered while selecting
reagent.
04
(c) Explain in detail the factors affecting the enzyme activity 07
Q.5 (a) Briefly describe Adsorption & factors affecting adsorption. 03
(b) Explain in detail Chromatography as a separation technique. 04
(c) Describe (1). cGMP violations (2). Qualifications in GMP 07
OR

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1
Seat No.: ________ Enrolment No.___________

GUJARAT TECHNOLOGICAL UNIVERSITY

BE - SEMESTER ? VII (New) EXAMINATION ? WINTER 2019
Subject Code: 2173602 Date: 23/11/2019

Subject Name: Process Technology of Drugs & Intermediates
Time: 10:30 AM TO 01:00 PM Total Marks: 70

Instructions:
1. Attempt all questions.
2. Make suitable assumptions wherever necessary.
3. Figures to the right indicate full marks.

MARKS

Q.1 (a) Define Process safety. Briefly explain the types of hazards 03
(b) Describe Simulated Bed Chromatography with a schematic diagram. 04
(c) Describe the resolution of Racemates by (1). Direct crystallization method,
(2). Preferential crystallization method with example and schematic
diagrams.
07
Q.2 (a) Why Good manufacturing Practices (GMP) are to be followed in Pharma
Industries? Where these guide lines are applicable? What are the importance
of GMP
03
(b) Describe the steps which are to be taken for optimizing reactions 04
(c) Briefly discuss the techniques for identifying exothermicity & gas
generation. Illustrate the use of calorimetry with three examples.
07
OR
(c) Discuss about (1). Choosing a Phase transfer catalyst (PTC), (2). How
selectivity in PTC can be achieved. Illustrate the advantages of using PTC in
any two organic synthesis
07
Q.3 (a) Why enzymes are preferred as catalyst? Describe the regulation of enzymes 03
(b) Define Chiral auxiliary.With a schematic diagram, illustrate the use of
Chemical Auxillary. Give one example of the use of Chiral auxillary
04
(c) What are the factors to be considered while choosing a solvent. Briefly
describe them.
07
OR
Q.3 (a) Discuss about Marckwald principle & Reciprocal resolution with example 03
(b) Discuss ?Residual solvents?. Write a note on classification of solvents by
risk assessment.
04
(c) Describe, (1). Adulterated drug, (2). Deviation investigation, (3). CAPA 07
Q.4 (a) Write a note on Supercritical liquid as solvent 03
(b) Discuss the steps to be taken for optimizing the mesylation of Propargylic
alcohol
04
(c) Write a note on classifications of Enzymes. Discuss in detail the Lipases &
Esterases and their catalytic reactions.
07
OR
Q.4 (a) Write a note on Enzymes & their sources. 03
(b) Define ?Reagent?. List out the factors to be considered while selecting
reagent.
04
(c) Explain in detail the factors affecting the enzyme activity 07
Q.5 (a) Briefly describe Adsorption & factors affecting adsorption. 03
(b) Explain in detail Chromatography as a separation technique. 04
(c) Describe (1). cGMP violations (2). Qualifications in GMP 07
OR

2
Q.5 (a) Briefly describe Reverse osmosis, Microfiltration & Ultra filtration
separation processes.
03
(b) What are the principle factors to be considered while selecting filtration
equipment. Explain the working of rotary drum filter & leaf filter with a
suitable diagram.
04
(c) Why documentation is important in GMP? List out the important documents
required under GMP. Write detailed notes on Process validation.
07

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